Clinical Laboratory Study Manager - FSP
Not Disclosed•Full-TimeRemote
location_onVermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States
About the Role
The Clinical Laboratory Study Manager serves as a critical bridge between scientific strategy and operational execution. Working closely with the Precision Medicine Strategy Lead, clinical study teams, and specialized groups such as Data Management (DM), Samples, Kits, Data, Logistics (SKDL), and Clinical Laboratory Project Management (CLPM), this role ensures the delivery of high-quality samples and data. The primary mission is to support biomarker and non-biomarker evaluations, enabling the translation of scientific discoveries into effective medicines.
In this position, you will oversee the entire lifecycle of clinical sample management, from collection and chain of custody to usage per informed consent forms, tracking, and eventual destruction. You will act as a key liaison between internal stakeholders and external vendors, including central and specialty laboratories, to ensure samples are collected strictly according to protocol. Your expertise will be vital in resolving sample-related queries and supporting Clinical Trial Management (CTM) and CRO partners.
Beyond operational oversight, you will drive project management aligned with core business strategies. This includes establishing and integrating processes for sample collection, processing, storage, shipping, and data transfer. You will also guide vendors and clinical sites on best practices for sample handling, prepare Requests for Proposals (RFPs), and manage vendor assessments and audits to ensure compliance and budget alignment.
Work location
Work model: Remote
Vermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States
Montpelier, Vermont
Key Responsibilities
- check_circlePrepare RFPs, review bids and SOWs for sample-related testing and logistics services
- check_circleProvide guidance and training to vendors and clinical sites on sample collection and storage procedures
- check_circleMonitor sample acquisition and testing at central and specialty labs to support clinical trial needs
- check_circleEstablish and oversee sample collection, processing, storage, shipping, and transfer workflows
- check_circleManage central laboratory and specialty vendors to ensure quality sample and data delivery
- check_circleCoordinate with project managers and CROs to ensure samples are collected per protocol
- check_circleOversee clinical sample collection, usage, tracking, and destruction per informed consent forms
- check_circleCollaborate with data management leads to define sample data capture, blinding, and transfer specifications
Requirements
- verifiedBachelor's degree in a life science, nursing qualification or other relevant field
- verified6-8 years direct clinical research lab study management experience within CRO or pharmaceutical/biotech industry
- verifiedWorking knowledge of clinical trials and clinical databases
- verifiedExperience with Microsoft applications
Nice to Have
Laboratory sample management experience
Similar Job Opportunities
Skills, education and keywords
Skills: Clinical Trials, Clinical Databases, Microsoft Applications, Laboratory Sample Management.
Education: Bachelor's degree in a life science required; Nursing qualification (Bachelor's level) required.
Frequently asked questions about Clinical Laboratory Study Manager - FSP at Parexel
What does a Clinical Laboratory Study Manager - FSP at Parexel do?expand_more
A Clinical Laboratory Study Manager - FSP at Parexel is responsible for the following: Prepare RFPs, review bids and SOWs for sample-related testing and logistics services; Provide guidance and training to vendors and clinical sites on sample collection and storage procedures; Monitor sample acquisition and testing at central and specialty labs to support clinical trial needs; and Establish and oversee sample collection, processing, storage, shipping, and transfer workflows.
What are the requirements for this Clinical Laboratory Study Manager - FSP role?expand_more
Parexel is looking for candidates who meet the following requirements: Bachelor's degree in a life science, nursing qualification or other relevant field; 6-8 years direct clinical research lab study management experience within CRO or pharmaceutical/biotech industry; Working knowledge of clinical trials and clinical databases; and Experience with Microsoft applications.
Where is the Clinical Laboratory Study Manager - FSP role at Parexel located?expand_more
Clinical Laboratory Study Manager - FSP at Parexel is based in Vermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States. This is a remote role.
Is this Clinical Laboratory Study Manager - FSP job remote, hybrid, or on-site?expand_more
Parexel has listed this Clinical Laboratory Study Manager - FSP role as remote.
How much experience is required for this Clinical Laboratory Study Manager - FSP role?expand_more
Clinical Laboratory Study Manager - FSP at Parexel typically requires 6–8 years of relevant experience at the senior level.
What skills do you need for the Clinical Laboratory Study Manager - FSP role at Parexel?expand_more
Key skills for Clinical Laboratory Study Manager - FSP at Parexel include Clinical Trials; Clinical Databases; Microsoft Applications; and Laboratory Sample Management.
What education is required for Clinical Laboratory Study Manager - FSP at Parexel?expand_more
Educational requirements for this role: Bachelor's degree in a life science required; and Nursing qualification (Bachelor's level) required.
What category does the Clinical Laboratory Study Manager - FSP role belong to?expand_more
Clinical Laboratory Study Manager - FSP at Parexel is part of the scientific & qa job category on Recrutus.